Juun 2022: Ka dib laba ama in ka badan oo daawaynta habaysan, FDA waxay ku abaalmarisay tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) waxay dedejisay oggolaanshaha bukaanka qaangaarka ah ee soo noqnoqda ama follicular follicular lymphoma (FL).
The approval was based on the results of the ELARA trial (NCT03568461), a multicenter, single-arm, open-label trial evaluating tisagenlecleucel, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, in adult patients who were refractory or relapsed within 6 months after completing two or more lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent) or Tisagenlecleucel was given as a single intravenous infusion after lymphodepleting chemotherapy, with a target dosage of 0.6 to 6.0 x 108 CAR-positive viable T cells.
Heerka jawaabta guud (ORR) iyo muddada jawaabta (DOR), sida ay dejiyeen guddiga dib u eegista madax-bannaan, ayaa ahaa tallaabooyinka waxtarka leh. ORR wuxuu ahaa 86 boqolkiiba (95 boqolkiiba CI: 77, 92) oo ka mid ah bukaannada 90 ee falanqaynta waxtarka aasaasiga ah, oo leh heerka CR ee 68 boqolkiiba (95 boqolkiiba CI: 57, 77). Dhexdhexaadka DOR lama kulmin, iyadoo 75% jawaab bixiyaasha (95 boqolkiiba CI: 63, 84) ay wali ka jawaabayaan 9 bilood ka dib. ORR wuxuu ahaa 86 boqolkiiba (95 boqolkiiba CI: 77, 92) dhammaan bukaannada qaba leukapheresis (n=98), oo leh heerka CR ee 67 boqolkiiba (95 boqolkiiba CI: 57, 76).
Calaamadaha sii deynta Cytokine, infection, weariness, musculoskeletal pain, headache, and diarrhoea were the most prevalent adverse effects in patients (>20 percent). 0.6 to 6.0 x 108 CAR-positive viable T cells is the suggested tisagenlecleucel dose.
